Shares of Amarin Corporation (Nasdaq:AMRN), are soaring in early trading after the biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from its ANCHOR trial for the Company's lead product candidate, AMR101. The Phase 3 trial, which was The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA, met its primary and secondary efficacy endpoints for both the 4 gram and 2 gram daily doses.
The company plans on hosting a conference call at 8:00 a.m. EDT today, to comment on the ANCHOR results and the Company's current operating and strategic objectives. To participate in the call, please dial (877) 407-0778 within the U.S. or (201) 689-8565 from outside the U.S. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call dial (877) 660-6853 (inside the U.S.) or (201) 612-7415 (outside the U.S.). As we told our subscribers, we felt positive top-line results in ANCHOR were very high, based on the MARINE data and two previous clinical studies
The purpose of the ANCHOR trial was to demonstrate that AMR101 is effective in reducing triglyceride levels in patients with high triglycerides without increasing LDL-C ("bad cholesterol") levels in patients on background statin therapy. Details of the findings can be found here: http://yhoo.it/AMRNstudyresults
"The design and execution of the ANCHOR trial were robust and the trial results were very clearly positive," said Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, and principal investigator of the ANCHOR trial. "I am very impressed with the performance of AMR101. In particular, whereas current triglyceride-lowering drugs may raise LDL-C and causes patient treatment concerns, AMR101 demonstrated a decrease in LDL-C beyond the decrease created by statin therapy. Furthermore, it is very encouraging for patient care that AMR101 caused reductions in significant markers of cardiovascular risk such as Apo B and non-HDL-C. The greater triglyceride reduction in patients with higher potency statin regimens is also very encouraging."
Commenting on the ANCHOR trial results, Joseph S. Zakrzewski, Chief Executive Officer and Executive Chairman of Amarin, stated, "We are delighted by the results of the ANCHOR trial. In November we announced MARINE trial results which position AMR101 to be best-in-class for treating patients with very high triglycerides. The ANCHOR trial results are even more remarkable than the broadly positive MARINE trial results. We believe these results clearly differentiate AMR101 from other triglyceride lowering therapies and position AMR101 to be both first-in-class and best overall therapy for treating the high triglyceride population. We thank the ANCHOR team, including our investigators, for their many contributions to this outstanding study design and execution."
Company officials report that in the U.S. alone, approximately 40 million people have triglyceride levels above 200 mg/dL. In the seven largest pharmaceutical markets (U.S., Japan and five largest European markets), it is estimated that over 100 million people have mixed dyslipidemia.
This morning, Canaccord Genuity life sciences analyst Ritu Baral said: “We reiterate our BUY rating and raise our target to $18 [from $11] on larger AMR101 commercial potential and impressive ANCHOR results this morning. AMR101 is AMRN’s purified EPA omega-3 drug for high triglycerides. We think AMRN may submit the AMR101 NDA for very high triglycerides in Q3/11 and get approval in H1/12. We are raising our pNPV-based target based higher projections for peak AMR101 sales in mixed dyslipidemia.”
BiomedReports believes Amarin is run by stellar management. In the past several months, Amarin has essentially reunited the key players from Reliant Pharmaceuticals, makers of Lovaza who were purchased by GSK for $1.65 billion. Current CEO Joe Zakrzewski, was at the time CEO of Reliant. Additionally, they just hired Paul E. Huff, as Chief Commerical Officer. Paul Huff played a pivotal role in the launch and successful commercialization of Lovaza and Niaspan, two very successful lipid products. Their executive team has serious credentials in the cardiovascular space, but more importantly, they have demonstrated the ability to execute on their product’s potential.
Wall Street funds had taken notice of the company as they saw a large increase in institutional holdings during the past few months. In addition, Amarin is widely seen as a likely acquisition target in 2011, especially with positive ANCHOR study results. Back in January at the JP Morgan Healthcare Conference, CEO Joe Zakrzewski, said “I have more companies interested in this asset(AMR-101) than employees,” The company employs 17 people. We will continue to following Amarin as their story develops.
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